(135 days)
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.
- . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.
The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.
The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:
- Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
- Get and set additional information about the connected device: ●
- o The battery level of the device
- The firmware version of the device o
- The serial number of the device o
- The volume level of the device o
- The filter currently being used in the auscultation O
- The hardware version of the device o
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
The eKuore Pro 4T is an electronic stethoscope intended for use by healthcare professionals for diagnostic decision support in clinical settings. It electronically filters and transfers sounds to compatible software, allowing for the recording of heart sounds, cardiac murmurs, bruits, respiratory sounds, and abdominal sounds in pediatric and adult patients.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table comparing them directly to device performance for the eKuore Pro 4T itself. Instead, it relies on demonstrating substantial equivalence to a predicate device (eKuore Pro Series, K203007) through a comparison of technological characteristics and compliance with various medical device standards.
| Acceptance Criteria Category | Device Performance / Comparison |
|---|---|
| Intended Use | Identical to predicate device |
| Indications for Use | Identical to predicate device |
| Regulatory Class | Identical to predicate device (Class II) |
| Classification Name | Identical to predicate device (Electronic Stethoscope) |
| Regulation Number | Identical to predicate device (21 CFR 870.1875) |
| Product Code | Identical to predicate device (DQD) |
| Manufacturer | Identical to predicate device (Chip Ideas Electronics, SL) |
| Principles of Operation | Similar to predicate device (main difference is output to eKuore Pro 4T Engine Java vs. smartphones/tablets) |
| Clinical Conditions | Identical to predicate device (Human body sounds related) |
| Use | Identical to predicate device (Electronic stethoscope) |
| Prescription/O.T.C. | Identical to predicate device (Prescription use) |
| Direct Connection to Patient | Identical to predicate device (YES) |
| Use Environment | Identical to predicate device (Clinical settings) |
| Type of Users | Identical to predicate device (Health-care personnel) |
| Target Population | Identical to predicate device (Pediatric and adult patients) |
| Cleaning & Maintenance | Identical to predicate device |
| Sound Track Transfer Function | Identical to predicate device (Yes) |
| Signal Transmission | Similar to predicate device (Wireless transmission to eKuore Pro 4T Engine Java vs. compatible smartphones/tablet via WiFi) |
| Energy Source | Identical to predicate device (Lithium-Ion Battery) |
| System Required | Different to predicate device (Platform compatible with Java VM vs. Android/Apple devices) |
| Hardware and Software Platforms | Different to predicate device (Desktop or Mobile devices vs. Mobile devices or tables) |
| Connections | Identical to predicate device (Micro USB for charging only) |
| Filter Frequency Range | Identical to predicate device (Heart: 50-150 Hz, Lung: 50-500 Hz, Extended: 40-600 Hz) |
| Wireless Data Transmission | Different to predicate device (Audio and configuration vs. Audio only) |
| Signal Input Method | Identical to predicate device (Sound waves collected via Transducer, Microelectro-mechanical microphone) |
| Audio Output Method | Similar to predicate device (Earbuds via 3.5mm Jack from device or device running eKuore Pro 4T engine audio output vs. from device or smartphone/tablet audio outputs) |
| Signal Storage | Different to predicate device (Depend on platform running eKuore Pro 4T engine vs. Depend on Smartphone/tablet internal memory) |
| Performance Requirements (Temp/Humidity) | Identical to predicate device (Temp range: 0°C to +40°C, Humidity range: 15% to 93%) |
| Body Material | Identical to predicate device (ABS) |
| Diaphragm Material | Identical to predicate device (Membrane: Epoxy and Fiberglass, Membrane's ring: PVC) |
| Contact with Human Tissues | Identical to predicate device (Chestpiece in contact with patients' skin) |
| Sterility | Identical to predicate device (Not intended to be sterilized) |
| Compliance with Standards | AAMI ANSI ES 60601-1:2005 and A1:2012, IEC 60601-1-2 Edition 4: 2014-02, IEC 62304:2015, AAMI ANSI IEC 62366:2007, ISO 14971:2007 |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device." However, it does not specify any sample size for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for any specific performance study related to the eKuore Pro 4T's diagnostic capabilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards rather than a clinical performance study with human experts establishing ground truth for a diagnostic task.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
No MRMC study is mentioned. The eKuore Pro 4T is described as a device that "electronically filter and transfer sounds to compatible software" and "can be used to record heart sounds...for diagnostic decision support." It is not presented as an AI-powered diagnostic tool, but rather as an electronic stethoscope that facilitates data transfer. Therefore, a comparative effectiveness study showing human reader improvement with AI assistance is not applicable in this context and not described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study is described. The device itself is an electronic stethoscope that captures and transmits sounds. The "eKuore Pro 4T Engine Java" is a library for third-party applications to communicate with the device, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The document does not describe any specific performance study that would require a defined ground truth (e.g., expert consensus, pathology, outcomes data) for diagnostic accuracy. The testing mentioned (non-clinical data, compliance with standards) relates to safety, electrical performance, software development, usability, and risk management rather than diagnostic accuracy against a clinical ground truth.
8. The Sample Size for the Training Set
This information is not provided because there is no mention of a machine learning or AI algorithm being trained by the device itself or an associated diagnostic software.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as no training set for an AI algorithm is mentioned.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 10, 2021
Chip Ideas Electronics S.L. Bernardo Plaza Regulatory Affairs Manager C/ Alfareria 3 B Burjasot, Valencia 46100 Spain
Re: K212013
Trade/Device Name: eKuore Pro 4T Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: October 1, 2021 Received: October 13, 2021
Dear Bernardo Plaza:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212013
Device Name
eKuore Pro 4T
Indications for Use (Describe)
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 - 510(k) Summary
SUBMITTER
Submitter name: Submitter address:
Chip Ideas Electronics, S.L. C/ Alfarería 3 B. 46100 Burjasot, Valencia SPAIN
Registration Number: Owner Operator Number: 3017140534 10075275
Contact person: Phone: e-mail:
Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com
Date Prepared:
2021-10-14
DEVICE
Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number: eKuore Pro 4T ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875
PREDICATE DEVICE
eKuore Pro Series (K203007) Predicate Device (S):
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Section 5 - 510(k) Summary
5.1 DEVICE DESCRIPTION
eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.
- . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.
The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.
The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:
- Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
- Get and set additional information about the connected device: ●
- o The battery level of the device
- The firmware version of the device o
- The serial number of the device o
- The volume level of the device o
- The filter currently being used in the auscultation O
- The hardware version of the device o
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
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eKuore Pro 4T 510(k) Premarket Notification
| Equipment description | |
|---|---|
| Image: eKuore Pro 4T main piece with the chestpiece attached | eKuore Pro 4T main piece with the chestpiece attached. |
| Image: Hand attaching chestpiece to eKuore Pro 4T | To use the eKure Pro 4T devices the chestpice must be attached and turn it on, as is shown in the pictogram.There are three models of chestpiece depend on the patient to be auscultated. S, M or L from neonatal to adults patients. |
| Image: Healthcare professional, Integration-Information, Software Sistem | eKuore Pro 4T device is connected via Wi-Fi to software built using eKuore Pro 4T engine. |
| Image: eKuore Pro 4T product packaging | eKuore Pro 4T product packaging. |
Section 5 – 510(k) Summary
Table 5.1 Equipment Description
The following table shows the difference and similarities of each eKuore Pro Series model:
| Characteristic | EP0002 | EP0099 | EP0098 |
|---|---|---|---|
| Form | Same for the three models | Same for the three models | Same for the three models |
| Design | Same for the three models | Same for the three models | Same for the three models |
| Material | Same for the three models | Same for the three models | Same for the three models |
| Function | For healthcare | For healthcare | For healthcare |
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
| professionals | professionals that needsincreased volume | professionals | |
|---|---|---|---|
| Connectivity | Create an WLAN accesspoint | Create an WLAN accesspoint | It connects to an WLANaccess point Configurablewith eKuore Pro 4T EngineJava library |
| Volume control /gain | 5 steps, 2 dB of differencebetween levels | 5 steps, 2 dB of differencebetween levels with anoffset of +6db | 5 steps, 2 dB of differencebetween levels |
| Energy Supply | Same for the three models | ||
| Software | Compatible with eKuorePro APP. | Compatible with eKuorePro APP. | No compatible with eKuorePro APP. Configurable witheKuore Pro Engine Javalibrary |
| Firmware | eKuore Pro FW v1.10.07 | eKuore Pro FW v1.10.07 | eKP4T FW v1.0.4 |
| DSP configuration | v00.00.08 | v00.00.58 | v00.00.08 |
| Hardware | Same for the three models |
Table 5.2 - eKuore Pro models comparison table
The following table shows the technical characteristics of eKuore Pro 4T
| Weight without chestpiece | 85 gr |
|---|---|
| Dimensions without chestpiece | 13cm x 5cm x 3cm (W x D x H) |
| Weight with chestpiece | 150 gr |
| Dimensions with chestpiece | 13cm x 5cm x 5cm (W x D x H) |
| Working temperature and humidity | 0 to +40 °C and +15 to +93% |
| Transportation and storage temperature andhumidity | -20 to +45°C and +15 to +93% |
| IP Rate | IP21 |
| Transmission frequency range | Beetween 2.412 GHz and 2.484 GHz |
| Modulation type | DSSS |
| Wireless quality of service | Device needs to be connected to wlan with atleast 705kbs |
| Wireless security | WLAN WPA2 encrypted networks preferred. |
| Input voltage during the load | 5V DC, 500 mA |
| Power | 2,5 W |
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
| Battery | Rechargeable. 1400 mAh lithium polymer. Donot replace by user |
|---|---|
| USB Port | Do not connect while the device iss being usedwith the patient |
| Wireless functions | Audio transmission |
| Wireless standard protocol | IEEE 802.11bg |
| Effective radiated power | 15dBm (32mW) |
Table 5.3 - eKuore Pro 4T technical characteristics
5.2 INDICATIONS FOR USE
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
5.3 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The electronic stethoscopes are mainly used on auscultation in the detection of cardiac, respiratory sounds and check other internal organs. These types of devices are used to digitize the data of the auscultation into a mobile device.
In the establishment of substantial equivalence, eKuore Pro 4T compared to the predicate device K203007, eKuore Pro Series:
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 – 510(k) Summary
| Elements ofcomparison | New Device | Predicate device | Comparison | |
|---|---|---|---|---|
| eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | ||
| Regulatory Class | Class II | Class II | Class II | Identical to predicate device |
| Classification name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device |
| Product code | DQD | DQD | DQD | Identical to predicate device |
| Manufacturer | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | Identical to predicate device |
| FDA Clearance | K212013 Pending | K203007 | K203007 | - |
| Indications for use | The eKuore Pro Series is intendedto be used as a part of a physicalassessment of a patient byhealthcare professionals fordiagnostic decision support inclinical settings. eKuore Pro Seriesis intended for use on pediatric andadult patients. It can electronicallyfilter and transfer sounds tocompatible software.It can be used to record heartsounds and cardiac murmurs, bruits,respiratory sounds and abdominalsounds during physical examinationin normal patients or those withsuspected diseases of the cardiac,vascular, pulmonary or abdominalorgan systems. | The eKuore Pro Series is intendedto be used as a part of a physicalassessment of a patient byhealthcare professionals fordiagnostic decision support inclinical settings. eKuore Pro Seriesis intended for use on pediatric andadult patients. It can electronicallyfilter and transfer sounds tocompatible software.It can be used to record heartsounds and cardiac murmurs, bruits,respiratory sounds and abdominalsounds during physical examinationin normal patients or those withsuspected diseases of the cardiac,vascular, pulmonary or abdominalorgan systems. | The eKuore Pro Series is intendedto be used as a part of a physicalassessment of a patient byhealthcare professionals fordiagnostic decision support inclinical settings. eKuore Pro Seriesis intended for use on pediatric andadult patients. It can electronicallyfilter and transfer sounds tocompatible software.It can be used to record heartsounds and cardiac murmurs, bruits,respiratory sounds and abdominalsounds during physical examinationin normal patients or those withsuspected diseases of the cardiac,vascular, pulmonary or abdominalorgan systems. | Identical to predicate device |
| Principles of operation | The device picks up sounds from apatient's body. This sound isfiltered, amplified and sent it to theuser through earbuds, also it can besent via WiFi to eKuore Pro 4T | The device picks up sounds from apatient's body. This sound isfiltered, amplified and sent it to theuser through earbuds, also it can besent via WiFi to compatible | The device picks up sounds from apatient's body. This sound isfiltered, amplified + 6dB offset andsent it to the user through earbuds,also it can be sent via WiFi to | Similar to predicate device |
| Elements ofcomparison | New Device | Predicate device | Comparison | |
| eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | ||
| Engine Java. | smartphones and tablets. | compatible smartphones andtablets. | ||
| Clinical conditions | Human body sounds related | Human body sounds related | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | Electronic stethoscope | Electronic stethoscope | Identical to predicate device |
| Prescription/O.T.C. | Prescription use | Prescription use | Prescription use | Identical to predicate device |
| Intended for DirectConnection to Patient | YES | YES | YES | Identical to predicate device |
| Use environment | Clinical settings | Clinical settings | Clinical settings | Identical to predicate device |
| Type of users | Health-care personnel | Health-care personnel | Health-care personnel with hearingdifficulties | Identical to predicate device |
| Target population | Pediatric and adult patients | Pediatric and adult patients | Pediatric and adult patients | Identical to predicate device |
| Cleaning &Maintenance | When the power supply is off, theentire plastic surface can be cleanedsliding an alcohol pad. Excess fluidduring cleaning can cause leakageof moisture on internal components.Clean the stethoscope from patientto patient | When the power supply is off, theentire plastic surface can be cleanedsliding an alcohol pad. Excess fluidduring cleaning can cause leakageof moisture on internal components.Clean the stethoscope from patientto patient. | When the power supply is off, theentire plastic surface can be cleanedsliding an alcohol pad. Excess fluidduring cleaning can cause leakageof moisture on internal components.Clean the stethoscope from patientto patient | Identical to predicate device |
| TECHNICAL EQUIVALENCE | ||||
| Sound track transferfunction | Yes | Yes | Yes | Identical to predicate device |
| Signal transmissionfor visualization | Wireless transmission to eKuorePro 4T Engine Java | Wireless transmission to compatiblesmartphones/ tablet via WiFi | Wireless transmission to compatiblesmartphones/ tablet via WiFi | Similar to predicate device. |
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | Lithium-Ion Battery | Identical to predicate device |
| System required | Platform compatible with Java VM | Android device and Apple, Inc | Android device and Apple, Inc | Different to predicate device |
| Hardware andsoftware platforms | Desktop or Mobile devices | Mobile devices or tables | Mobile devices or tables | Different to predicate device |
| Connections | Micro USB connector only tocharge the internal battery of thedevice | Micro USB connector only tocharge the internal battery of thedevice | Micro USB connector only tocharge the internal battery of thedevice | Identical to predicate device |
| Elements ofcomparison | New Device | Predicate device | Comparison | |
| comparison | eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | |
| Filter frequency range | • Heart (50-150 Hz)• Lung (50-500 Hz)• Extended (40-600 Hz) | • Heart (50-150 Hz)• Lung (50-500 Hz)• Extended (40-600 Hz) | • Heart (50-150 Hz)• Lung (50-500 Hz)• Extended (40-600 Hz) | Identical to predicate device |
| Wireless datatransmission | Audio and configuration | Audio | Audio | Different to predicate device |
| Signal Input Method | Sound waves collected via aTransducer. Microelectro-mechanical microphone | Sound waves collected via aTransducer. Microelectro-mechanical microphone | Sound waves collected via aTransducer. Microelectro-mechanical microphone | Identical to predicate device |
| Audio Output Method | Earbuds connected with the devicethrough the 3.5mm Jack directly tothe eKuore device or from thedevice running eKuore Pro 4Tengine audio output | Earbuds connected with the devicethrough the 3.5mm Jack directly tothe eKuore device or from thesmartphone/tablet audio outputs | Earbuds connected with the devicethrough the 3.5mm Jack directly tothe eKuore device or from thesmartphone/tablet audio outputs | Similar to predicate device |
| Signal Storage | Depend on platform runningeKuore Pro 4T engine. | Depend on Smartphone/tabletinternal memory, eKuore Pro Applets the user record 30, 60, 90 or120 seconds. eKuore Pro Seriesdevices does not stored data. | Depend on Smartphone/tabletinternal memory, eKuore Pro Applets the user record 30, 60, 90 or120 seconds. eKuore Pro Seriesdevices does not stored data. | Different to predicate device |
| Performancerequirements | Temp range: 0°C to +40°CHumidity range: 15% to 93% | Temp range: 0°C to +40°CHumidity range: 15% to 93% | Temp range: 0°C to +40°CHumidity range: 15% to 93% | Identical to predicate device |
| BIOLOGICAL EQUIVALENCE | ||||
| Body material | ABS (Acrylonitrile ButadieneStyrene) | ABS (Acrylonitrile ButadieneStyrene) | ABS (Acrylonitrile ButadieneStyrene) | Identical to predicate device |
| Diaphragm material | Membrane: Epoxy and FiberglassMembrane's ring: PVC | Membrane: Epoxy and FiberglassMembrane's ring: PVC | Membrane: Epoxy and FiberglassMembrane's ring: PVC | Identical to predicate device |
| Contact with humantissues or body fluids | The chestpiece is in contact withpatients' skin. | The chestpiece is in contact withpatients' skin. | The chestpiece is in contact withpatients' skin. | Identical to predicate device |
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Not intended to be sterilized | Identical to predicate device |
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
Table 5.4. Substantial Equivalence Comparison – eKuore Pro Series and Predicate Device K203007
Rev 07
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eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
Information provided in these 510(k) submissions shows that eKuore Pro 4T is substantially equivalent to the predicate device eKuore Pro Series cleared under K203007 in terms of intended use, indications for use, compatibility, and technological characteristics. There are no new questions of safety or effectiveness.
Summary discussion of non-clinical data:
The proposed device has been designed, developed, tested, verified, and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
General requirements for basic safety standard requirements for medical electrical equipment test have been successfully complete following standard of AAMI ANSI ES 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02 as being equivalent to the predicate device.
Integration verification and validation testing have been successfully complete following standard IEC 62304:2015.
Usability testing requirements have been evaluated and successfully met as per standards AAMI ANSI IEC 62366:2007.
Design and development included identification, and control of potential hazards as per standard ISO 14971:2007.
Summary discussion of clinical data:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
5.4 CONCLUSIONS
Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore Pro Series is substantially equivalent to the listed legally marketed predicate device.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.